氢溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.813411903420353421953409703416683416120.16
214.823404683416593410640.25
单位质量响应值RSD%判断
23066.3123013.770.17数据可信
供试品溶液-by1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227749-22774957.36051.0224.7457.3651.0224.74
2232608-23260858.58458.58
3234172-23417258.97858.98
4113582-11358228.60628.61
5171257-17125743.13243.13
6236058-23605859.45359.45
10min1381868-38186896.17687.9114.3496.2787.9914.36
2367480-36748092.55292.65
3385252-38525297.02897.13
4262673-26267366.15666.20
5314313-31431379.16279.23
6382685-38268596.38196.48
15min1412236-412236103.824100.665.94104.08100.895.96
2403006-403006101.499101.75
3420531-420531105.913106.17
4356082-35608289.68189.84
5391230-39123098.53498.74
6414957-414957104.509104.77
20min1410856-410856103.477103.801.62103.91104.201.63
2403371-403371101.591102.01
3420986-420986106.028106.46
4406141-406141102.289102.60
5416671-416671104.941105.31
6414907-414907104.497104.93
30min1411950-411950103.752104.501.72104.35105.071.71
2403444-403444101.610102.20
3424693-424693106.961107.57
4418863-418863105.493105.97
5416409-416409104.875105.42
6414228-414228104.326104.93
45min1409169-409169103.052104.011.68103.83104.761.66
2401422-401422101.101101.86
3419927-419927105.761106.55
4419074-419074105.546106.20
5415593-415593104.670105.39
6412655-412655103.930104.71
极限1409635-409635103.169103.831.81104.12104.751.78
2398950-398950100.478101.41
3419148-419148105.565106.53
4418340-418340105.361106.19
5414970-414970104.513105.40
6412485-412485103.887104.84
氢溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.813408693415793406323412733420393412780.17
214.823405423410753408080.12
单位质量响应值RSD%判断
23043.7522996.490.15数据可信
供试品溶液-by3批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187651-18765147.30248.563.8647.3048.553.86
2199312-19931250.24150.24
3197064-19706449.67549.67
4200581-20058150.56150.56
5188996-18899647.64147.64
6182146-18214645.91445.91
10min1362135-36213591.28591.671.8491.3691.751.84
2368606-36860692.91693.00
3367161-36716192.55292.63
4366331-36633192.34292.43
5367009-36700992.51392.59
6350835-35083588.43688.51
15min1431065-431065108.660106.591.53108.89106.821.52
2421388-421388106.221106.46
3415800-415800104.812105.05
4418775-418775105.562105.80
5430572-430572108.536108.77
6419484-419484105.741105.96
20min1435556-435556109.792107.051.76110.20107.461.76
2417858-417858105.331105.75
3417742-417742105.302105.71
4420759-420759106.062106.48
5431792-431792108.843109.26
6424340-424340106.965107.37
30min1434937-434937109.636106.931.78110.23107.521.77
2421454-421454106.237106.83
3416655-416655105.028105.62
4417127-417127105.147105.74
5431479-431479108.765109.36
6423537-423537106.763107.34
45min1434452-434452109.514106.641.76110.29107.401.75
2417412-417412105.219105.99
3416419-416419104.968105.73
4417810-417810105.319106.09
5429493-429493108.264109.04
6422638-422638106.536107.29
极限1434541-434541109.536106.621.83110.50107.571.83
2419988-419988105.868106.81
3414787-414787104.557105.49
4416778-416778105.059106.00
5430017-430017108.396109.35
6421832-421832106.333107.27
氢溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.816821816832006833496823206833946828890.09
214.826796556826426811480.32
单位质量响应值RSD%判断
46109.9945961.400.23数据可信
供试品溶液-by2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1225448-22544828.41833.139.6028.4233.139.60
2264573-26457333.34933.35
3287257-28725736.20936.21
4243162-24316230.65030.65
5290914-29091436.67036.67
6265580-26558033.47633.48
10min1497699-49769962.73570.106.3362.7870.166.33
2562475-56247570.90070.96
3577590-57759072.80572.87
4535258-53525867.46967.52
5597742-59774275.34575.41
6565898-56589871.33171.39
15min1686109-68610986.48492.233.6786.6492.403.67
2737359-73735992.94493.12
3745008-74500893.90894.09
4714557-71455790.07090.23
5758701-75870195.63495.82
6748309-74830994.32494.50
20min1776216-77621697.842100.812.0698.14101.132.06
2811468-811468102.285102.61
3800531-800531100.907101.24
4795419-795419100.262100.58
5791292-79129299.742100.09
6823559-823559103.809104.14
30min1790721-79072199.670101.131.69100.13101.621.69
2811111-811111102.240102.74
3800512-800512100.904101.41
4797807-797807100.563101.04
5788995-78899599.45299.96
6824773-824773103.962104.47
45min1788386-78838699.376101.031.82100.00101.691.81
2812403-812403102.403103.07
3799201-799201100.739101.41
4798192-798192100.612101.26
5786535-78653599.14299.82
6824408-824408103.916104.59
极限1786016-78601699.077100.661.7999.87101.491.79
2807088-807088101.733102.57
3795985-795985100.334101.18
4795990-795990100.334101.15
5784057-78405798.83099.67
6822297-822297103.650104.50
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